Statement From:Janet Woodcock, M.D.Principal Deputy Commissioner – Office of the Commissioner January 26, 2023 Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug...
Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due...
Today, the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against LGM Pharma LLC, an importer and distributor...
Company Must Stop Marketing Unauthorized Products or Risk Enforcement Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed...
Today, the U.S. Food and Drug Administration is announcing draft guidance for industry on action levels for lead in processed foods that are intended for babies...
U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose...
ANKARA, Turkey (Newswire.com) – Digital health start-up H2o therapeutics received 510(k) marketing clearance from the U.S. Food and Drug Administration for its prescription mobile app Parky for monitoring Parkinson’s Disease. Parky...
U.S. FDA approved Hemgenix, an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, or...
The U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular...
The U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8...
